Administration Set Docking Station
The Administration Set Docking Station (product code ODI) is a general hospital device used for temporary aseptic closure of the male Luer connector of an IV administration set between uses, maintaining sterility and preventing contamination for the life of the set. It provides a safe, closed-system docking point for intravenous tubing. This device is FDA Class 2 under regulation 880.5440 in the General Hospital specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- ODI
- Device Class
- FDA class 2
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
Temporary closing IV administration set. Temporary aseptic closure of the male Luer connector of the IV tubing in between uses for the life of the administration set.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K070163 | SWABBABLE CAP, MODEL 60205 | Aug 03, 2007 | Substantially Equivalent | Baxa Corp. |